FDA.reportPublic FDA data

OralTox

Primary DI
B313OT804041
Brand
OralTox
Company
PREMIER BIOTECH, INC
Model
OT80404
Device description
4 Panel OralTox - AMP/COC/OPI/PCP
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171403000OralTox Oral Fluid Drug TestPremier Biotech, Inc.2018-02-02DJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B313OT804041PrimaryHIBCC0
B3130T804040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010118759
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B313OT804011OralToxOT804012018-09-24
B313OT804021OralToxOT804022018-09-27
B313OT805021OralToxOT805022018-09-24
B313OT805041OralToxOT805042018-09-24
B313OT805081OralToxOT805082018-09-24
B313OT805091OralToxOT805092018-09-24
B313OT805101OralToxOT805102018-09-24
B313OT806021OralToxOT806022018-09-24
B313OT806051OralToxOT806052018-09-24
B313OT806221OralToxOT806222018-09-24
B313OT807011OralToxOT807012018-09-24
B313OT808071OralToxOT808072018-09-24
B313PBCARD01AMP5001Premier Bio-Cup & Bio-DipPBCard-01-AMP500PBCard-01-AMP5002018-01-23
B313PBCARD01BAR3001Premier Bio-Cup & Bio-DipPBCard-01-BAR300PBCard-01-BAR3002017-09-25
B313PBCARD01BZO3001Premier Bio-Cup & Bio-DipPBCard-01-BZO300PBCard-01-BZO3002017-09-25
B313PBCARD01COC1501Premier Bio-Cup & Bio-DipPBCard-01-COC150PBCard-01-COC1502017-09-25
B313PBCARD01OPI20001Premier Bio-Cup & Bio-DipPBCard-01-OPI2000PBCard-01-OPI20002017-09-25
B313PBCARD01PCP1Premier Bio-Cup & Bio-DipPBCard-01-PCPPBCard-01-PCP2017-09-25
B313PBCARD01THC501Premier Bio-Cup & Bio-DipPBCard-01-THC50PBCard-01-THC502017-09-25
B313PBCARD03041Premier Bio-Cup & Bio-DipPBCard-03-04PBCard-03-042017-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LCM2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLCM2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03